Label: 5% MINOXIDIL HAIR REGROWTH FOAM- minoxidil aerosol, foam

  • NDC Code(s): 85038-003-01, 85038-003-02, 85038-003-03
  • Packager: Lianjiang Shanlilai E-commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 11, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    5% Minoxidil Hair Regrowth Foam

  • ACTIVE INGREDIENT

    Minoxidil 5%
    Biotin 0.5%

  • PURPOSE

    Hair regrowth treatment

  • INDICATIONS & USAGE

    Use to regrow hair on the top of the scalp

  • WARNINGS

    For external use only. For use by men only.
    Extremely Flammable:Avoid fire, flame, or smoking during andimmediately following application.

  • DO NOT USE

    you are a woman.
    your amount of hair loss is different than that shown on side ofthis carton or your hair loss is on the front of the scalp.5% minoxidilfoam is not intended for frontal baldness or receding hairline.
    You have no family history of hair loss.
    Your hair loss is sudden andjor patchy.
    You do not know the reason for your hair loss.
    You are under 18 years of age. Do not use on babies and children.
    You use other medicines on the scalp.
    Your scalp is red, inflamed, infected, irritated, or painful.

  • WHEN USING

    Do not apply on other parts of the body.
    Avoid contact with the eyes. in case of accidental contact, rinseeyes with large amounts of cool tap water.
    Some people have experienced changes in hair color and,;or textureit takes time to regrow hair, Results may occur at 3 months withtwice a day usage. For some men, you may need to use this productfor at least 6 months before you see results.
    The amount of hair regrowth is different for each person.This product will not work for all men.

  • STOP USE

    if chest pain, rapid heartbeat, faintness, or dizziness occurs.
    if sudden, unexplained weight gain occurs.
    if your hands or feet swell.
    if scalp irritation or redness occurs.
    if unwanted facial hair growth occurs.
    if you do not see hair regrowth in 6 months.

  • KEEP OUT OF REACH OF CHILDREN

    lf swallowed, get medical help or contact a Poison ControlCenter right away.(1-800-222-1222)right away.

  • DOSAGE & ADMINISTRATION

    See enclosed leaflet for complete directions on how to use.
    Apply half a capful twice daily directly to the scalp in the hair lossarea.
    Massage into scalp with fingers, then wash hands well.
    Using more or more often will not improve results.
    Continued use is necessary to increase and keep your hair regrowthor hair loss will begin again.

  • STORAGE AND HANDLING

    Before use, read all information on carton and enclosed leaflet

    Store at controlled room temperature 20° to 25°C (68° to 77°F).

    Do not incinerate container. Do not expose to heat or store attemperature above 120°F(49°C).

  • INACTIVE INGREDIENT

    ALCOHOL
    GLYCERIN
    CETYL ALCOHOL
    STEARYL ALCOHOL
    POLYSORBATE 80
    ANHYDROUS CITRIC ACID
    LACTIC ACID
    CASTOR OIL
    .ALPHA.-TOCOPHEROL
    EDETATE DISODIUM
    WATER

  • PRINCIPAL DISPLAY PANEL

    labellabel2label3

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL HAIR REGROWTH FOAM 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85038-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85038-003-011 in 1 PACKAGE12/11/2024
    160 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:85038-003-022 in 1 PACKAGE12/11/2024
    260 g in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:85038-003-033 in 1 PACKAGE12/11/2024
    360 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/11/2024
    Labeler - Lianjiang Shanlilai E-commerce Co., Ltd. (638192827)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lianjiang Shanlilai E-commerce Co., Ltd.638192827manufacture(85038-003)